Colistin Versus Colistin Plus Fosfomycin for Infections Caused by MDR Acinetobacter Baumannii

Drug Safety Clinical Trial

Official title:

Colistin Plus Fosfomycin in Multi-Drug Resistant Acinetobacter Baumannii

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01297894
• Other study ID #: Siriraj CEU53-001
• Status: Recruiting
• Phase: Phase 3
• First received: February 15, 2011
• Last updated: December 24, 2011
• Start date: June 2010
• Est. completion date: May 2012

Study information

• Verified date: December 2011
• Source: Mahidol University
• Contact: Dr Visanu Thamlikitkul, Professor
• Phone: 662-419-6626
• Email: sivth[@]mahidol.ac.th
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

In Siriraj Hospital, colistin alone for treatment of MDR A. baumannii contributed to mortality 45% Fosfomycin is an antimicrobial which has activity against gram-negative bacterial including MDR A. baumannii In this study, we compare the clinical and microbiologicalresponse of colistin alone versus colistin plus fosfomycin in treatment of A. baumannii infected patients

Description:

Inclusion criteria

• Age> 18 years

• Hospitalized to Siriraj Hospital

• Infected caused by A. baumannii

• Need Colistin treatment

Exclusion criteria

• Pregnancy or Lactating mother

• Colistin or Fosfomycin Allergy

• Patients who have severe abnormal renal or liver function

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age> 18 years

• Hospitalized to Siriraj Hospital

• Infected caused by A. baumannii

• Need Colistin treatment

Exclusion criteria:

• Pregnancy or Lactating mother

• Colistin or Fosfomycin Allergy

• Patients who have severe abnormal renal or liver function

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Drug Safety

Intervention

Drug:
• colistin
Colistimethate sodium 2.5-5mg/kg of colistin base
• colistin plus fosfomycin
colitimethate sodium 2.5-5mg/kg iv plus fosfomycin 2gm iv every 12 hours

Locations

Country	Name	City	State
Thailand	Siriraj Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of subjects with cure or improvement	cure improvement worse death	up to 28days	Yes
Secondary	number of subjects with eradication of causative bacteria	eradication persistence superinfection	up to 28days	Yes